Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

November 1, 2017 updated by: Yonsei University
Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or Females, aged≥20 years and ≤80 years
  2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
  3. American Society of Anesthesiolosists (ASA) score of 1 to 3
  4. Histologically confirmed adenocarcinoma in stomach
  5. Clinical stage I (T1N0M0, T2N0M0, T1N1M0)

5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study

Exclusion Criteria:

  1. M1 status
  2. Experience of previous gastric resection
  3. Complication due to gastric cancer, such as complete obstruction or perforation
  4. History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer
  5. History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIR with ICG group
Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
Time Frame: About 7 days after operation when pathologic result was reported
About 7 days after operation when pathologic result was reported

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

January 31, 2014

Study Completion (Actual)

January 31, 2014

Study Registration Dates

First Submitted

August 18, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 21, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0414

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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